System and method for therapy

ABSTRACT

Disclosed is a system for stimulation of a subject. The stimulation may be to provide therapy to treat the subject. Stimulation may be of selected muscle groups and/or portions.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application includes subject matter related to U.S. patentapplication Ser. No. 16/752,236, filed on Jan. 24, 2020; U.S. patentapplication Ser. No. 16/752,274, filed on Jan. 24, 2020; and U.S. patentapplication Ser. No. 16/752,285, filed on Jan. 24, 2020. The entiredisclosure(s) of (each of) the above application(s) is (are)incorporated herein by reference.

FIELD

Disclosed is a system to apply therapy to a subject, and particularly toprovide therapy regarding stimulation and/or activation of muscletissue.

BACKGROUND

This section provides background information related to the presentdisclosure which is not necessarily prior art.

A subject may have a condition that may be harmful to the subject, suchas over a period of time. One condition may include obstruction of anairway for an air-breathing subject, such as a human. Several conditionsexist that may obstruct an airway and are generally referred to asobstructive sleep apnea (OSA) and/or upper airway restrictive/resistancesyndrome (UARS).

OSA and UARS may affect a subject by limiting airflow and, therefore,oxygen saturation. Low oxygen saturation may lead to various furtherundesired conditions. Treatment of these conditions often requires anexternal device to assist in providing airflow to a subject.

SUMMARY

This section provides a general summary of the disclosure, and is not acomprehensive disclosure of its full scope or all of its features.

Treatment of obstructive sleep apnea (OSA) and/or upper airwayrestrictive/resistance syndrome (UARS) may be provided by stimulating aselected portion of a subject. The stimulation may be provided by animplanted device. Thus, the treatment may be provided without anexternally worn or applied system. Treatment, therefore, may beautomatic and less or non-obtrusive.

In various embodiments, a stimulation system may be provided to asubject to stimulate various portions of the subject. The stimulationsystem may include a system that is able to provide an electricalstimulation, or other appropriate stimulation, from a source to asubject, such as through a lead. The lead may include one or morecontacts or electrodes to provide the stimulation from the source to theselected area. The source may include a generator and/or a power sourceto provide the stimulation to a selected area.

To treat OSA and/or UARS the stimulation may be to a portion of alingual muscle. The stimulation may be provided through the lead from animplanted stimulator according to at least one waveform and/orconfiguration. Further, the system may include a learning and/or testingphase to select one or more patterns or configurations. The selectedpatterns may be predetermined or determined in real time based onfeedback from selected one or more sensors and/or individuals (e.g.subject, clinician, etc.)

In various embodiments, the subject may be a mechanical system to whicha stimulation, such as an electrical stimulation, may be provided. Forexample, a powered component may be provided with an electricalstimulation to provide movement of a selected portion of the poweredcomponents. In various embodiments, however, the stimulation may beprovided to a human subject or an animal subject to stimulate a selectedportion of the subject. The stimulation may include the electricalstimulation to cause a selected muscle to activate and stiffen orcontract. Contraction of a muscle, as is generally understood by oneskilled in the art, may cause a muscle to contract and shorten to causemovement of a selected subject portion, such as an appendage, a muscletissue portion, or other selected portion of the subject.

Further areas of applicability will become apparent from the descriptionprovided herein. The description and specific examples in this summaryare intended for purposes of illustration only and are not intended tolimit the scope of the present disclosure.

DRAWINGS

The drawings described herein are for illustrative purposes only ofselected embodiments and not all possible implementations, and are notintended to limit the scope of the present disclosure.

FIG. 1 is a schematic illustration of a stimulation system;

FIG. 2 is a schematic illustration of an implantation position of astimulation system;

FIG. 3 is a detail superior-to-inferior view of a selected implantationlocation;

FIG. 4 is a medial-to-lateral view of a selected location of animplantation, according to various embodiments;

FIGS. 5A to 5G illustrate exemplary waveforms for stimulation of asubject, according to various embodiments;

FIGS. 6A to 6C illustrate exemplary lead contact stimulationconfigurations (e.g. bipolar from an anode to a cathode) for stimulationof a subject, according to various embodiments;

FIG. 7 is a flowchart illustrating a stimulation systemuse/training/testing, according to various embodiments;

FIG. 8 is a flowchart illustrating a stimulation systemuse/training/testing, according to various embodiments;

FIG. 9 is a flowchart illustrating a stimulation systemuse/training/testing, according to various embodiments; and

FIG. 10 is a flowchart illustrating a stimulation systemuse/training/testing, according to various embodiments.

Corresponding reference numerals indicate corresponding parts throughoutthe several views of the drawings.

DETAILED DESCRIPTION

Example embodiments will now be described more fully with reference tothe accompanying drawings.

With initial reference to FIG. 1 and FIG. 2, a stimulation assembly orsystem 20 is illustrated. The stimulation system 20 may include variouscomponents, or selected components of the system 20 as discussed furtherherein. In various embodiments, the stimulation system 20 may beprovided for treatment of Obstructive Sleep Apnea (OSA) and/or upperairway restrictive/resistance syndrome (UARS). The stimulation system 20may include various features and/or systems for the treatment, such asan implantable stimulation assembly 24 that may include, according tovarious embodiments, an implantable device (ID) 30. The ID may beimplanted and operated (e.g. by instructions stored therein) to providestimulation to a lingual muscle (i.e. tongue) of a subject 62. Thestimulation may be provided to ensure maintaining an open airway and/orre-open an airway.

The ID 30 may be implanted in the subject 62, as discussed herein.Interconnected with the ID 30, as a part of the implantable stimulationassembly 24, may be one or more lead assemblies 34. In variousembodiments, for example, the lead assembly 34 may be connected to theID 30 at a selected connection point 36 and extend to a first lead orstimulator portion (also referred to as a lead end) 40, and a secondlead or stimulator portion (also referred to as a lead end) 44. Invarious embodiments, as also discussed further herein, stimulation maybe provided to the subject through the lead ends 40, 44 to treat the OSAand/or UARS condition of the subject 62. The two lead ends 40, 44 may beused in selected or varying manners to reduce or eliminated fatigue ofthe lingual muscle to assist in increasing efficacy or success of atreatment.

The ID 30 may also include various components such as a power source(e.g. a battery) 48. The battery 48 may be rechargeable and recharged ina selected manner, such as through inductive recharging, which isgenerally understood in the art. The battery 48 may be charged via awired or wireless charging system. Wireless or contactless rechargingmodalities may include inductive recharging, resonant recharging, etc.Exemplary stimulation systems that include rechargeable batteriesinclude the Intellis® implantable neuro stimulator sold by Medtronic,Inc. having a place of business in Minneapolis, Minn. It is understood,however, that any appropriate power storage system may be provided andthe battery is merely exemplary. The power source 48 is to provide aselected current and/or voltage between one or more electrodes of thelead assembly 34, as discussed further herein.

The ID 30 may further include selected components to assist in providingstimulation through the lead assembly 34. For example, the ID 30 mayinclude a processor module 50 that may be any appropriate processor, asdiscussed further herein, to execute instructions provided to the ID 30from an external source and/or saved on a memory module 54. The memorymodule 54 may be any appropriate memory system, such as those discussedfurther herein. Further, the ID 30 may include a selected transceiversystem or module 58 that may be used to transmit and/or receiveinformation and/or instructions from an external source. The transceivermodule 58 may be any appropriate transceiver module such as thosediscussed further in.

The stimulation assembly 20 may include, according to variousembodiments, the implantable stimulation portion 24 as a stand-alonesystem. In various embodiments, the memory module 54 may include anyappropriate instruction and/or algorithms for operation of thestimulation portion 24. The processor module 50 may execute theinstructions from the memory module 54 and the battery 48 may beprovided to power the stimulation portion 24. It is understood, however,that various portions may also be provided external to a subject 62(FIG. 2) to assist in interacting with the ID 30.

Various sensors may be provided to transmit and/or receive a signalregarding the subject 62. A sensor 61 may be included with the ID 30(e.g. formed on an exterior of the ID 30, placed within the ID 30,and/or connected to the ID 30). The sensor 61 may include one or more ofan accelerometer, a global positioning system, oximeter,electromyography sensor, etc. The sensor 61 may be used to assist indetermining selection of treatment for the subject 62, as discussedherein. It is understood that the sensor 61 may also communicate withother systems. Also, or in addition to the sensor 61, an external orwearable sensor 61′ may be placed on the subject 62. The wearable sensor61′ may be the same sensors as discussed above, including redundantthereto. The wearable sensor 61′ may also include additional ordifferent sensors. Sensors, particularly external sensors, may include aposition (e.g. relative to gravity) sensor, temperature sensor, CO₂detector, airflow (e.g. nasal or mouth) detector, microphone (e.g. fordetecting breathing sounds (like snoring), impedance detector (e.g. todetect lung volume). Further, various sensors may be used to determineor monitor “quality of sleep” such as sensing via EEG or integration ofvarious sensors already mentioned. A quality of sleep determination maybe correlated to OSA therapy effectiveness. Regardless of the type, thesensor in the wearable sensor 61′ may also communicate with the ID 30and/or other portions of the system 20.

External systems, as a part of the stimulation assembly 20, may includea first external controller or transceiver 70. The first externaltransceiver 70 may also be referred to as a communication telemetrymodule (CTM) 70 that may communicate with the ID 30. In variousembodiments, the stimulation assembly 20 may further include a secondtransmission and/or control module (CTM) 74. The second control module74 may communicate with the first control module 70, for variouspurposes as discussed further herein, may communicate directly with theID 30, and/or may communicate with the ID 30 through the firsttransmission module 70. It is understood, however, that only one of thefirst transmission modules 70 or the second transmission module 74 maybe provided for the stimulation assembly 20.

The first CTM 70 may be provided to the user 62 for a personal and/or athome use. As discussed further herein, the CTM 70 may be used by theuser 62 to assist in controlling the ID 30 to provide stimulation to theuser 62. The CTM 70 may also be used to alter operation of the ID 30,such as by the user 62, input indications from a user 62, or otherappropriate mechanisms.

Briefly, the CTM 70 may include a body or module portion 78 that issized to fit within a hand of the user 62. Accordingly, the CTM 70 maybe mobile relative to the user 62 and/or allow for ease of transport anduse by the user 62. Further, the CTM 70 may be positioned near the user62 at any appropriate time, such as during a selected or near a sleepperiod of the user 62. The CTM 70 may further include one or more inputportions, such as a physical or also referred to as a hard button orhard selection assembly 82 that may include one or more buttons thatallow the user 62 to input operation or select operations of the ID 30.For example, the hard buttons 82 may include a start and stop button 84,a timer button 86, and/or a power or emergency button 88. The CTM 70 mayalso include a selected display 92 to provide information to the user 62such as a pulse rate, oxygen saturation value, breathing rate, or otherappropriate information. The display 92 may provide information, such ashistorical information, to a clinician for selecting programming andoperation of the ID 30. The display 92 may also be a touchscreen ortouch sensitive and, therefore, include one or more soft buttons.

The CTM 70 may include various components, such as a processor module100, a memory module 102, and a communication or transceiver module 104.The processor module 100, the memory module 102, and the transceivermodule 104 may be similar to those discussed further herein. Asillustrated in FIG. 1, the CTM 70 may transmit a signal, such as awireless signal 108 to the ID 30. Further, the ID 30 may transmit asignal, such as a wireless signal 110, to the CTM 70. Accordingly, theCTM 70 may receive information from the ID 30 and/or transmitinformation to the ID 30, and vice versa. As discussed herein, the CTM70 may be used to program or select operation of the ID 30 and the ID 30may include sensors to transmit information to the CTM 70. The CTM 70may be configured as any appropriate device and/or may be incorporatedas an application with an appropriate mobile computer (e.g. mobilephone, tablet, etc.). The application may be made for any appropriateoperating system such as the iOS operating system, Android® operatingsystem, etc. Also, the CTM 70 may be powered in an appropriate manner,such as with an internal battery that may be charged via a wired orwireless charging system. Wireless or contactless recharging modalitiesmay include inductive recharging, resonant recharging, etc.

The stimulation assembly 20 may further include a second control module,such as a CTM 74. The CTM 74 may include components similar to the firstCTM 70. The CTM 74, however, may be a larger and/or permanent deviceprovided with a clinician for operation of the ID 30 and/or programmingof the first CTM 70. The second CTM 74 may generally be non-mobile, inother words not intended to be moved with or by the subject 62.Accordingly, the second CTM 74 may include various hard buttons 120, atouch screen 124, a processor module 126, a memory module 128, and atransceiver module 130. Thus, the CTM 74 may transmit a signal, such asa wireless signal 140, to the first CTM 70 and/or the ID 30. Thus, theID 30 may also transmit the signal 110 to the CTM 74 and/or the firstCTM 70 may transmit a signal to the second CTM 74.

Accordingly, the simulation assembly 20 may include various componentsfor operation of the ID 30 according to selected embodiments, and invarious applications. The ID 30 may be implanted in the subject 62 forstimulation of the subject 62 according to a selected mechanism ormethod, as discussed further herein. Various control modules may beprovided at selected times to allow for programming of the ID 30,altering of the programming of the ID 30, receiving output (e.g.historical sensor data) from the ID 30, and analysis of operation of theID 30, historical data, and other information. In this manner, the firstCTM 70 may be provided for substantially immediate use and/or adjacentuse during operation and/or after implantation of the ID 30. The secondCTM 74 may be provided for initial programming, follow up, andinteraction with the subject and/or a central data storage and/oranalysis system by selected users, such as the clinician.

With continuing reference to FIG. 1 and additional reference to FIG. 2,the stimulation portion 24 may be implanted into a selected subject 62.As illustrated in FIG. 2, the selected subject 62 may be a humansubject. It is understood, however, that any appropriate subject mayhave the stimulation portion 24 positioned therewith at appropriatetimes. It is further understood that the ID 30 may be positioned near orexternal to the subject 62 such that the lead portion 34 is implantedpercutaneously into the subject 62 and the ID 30 (e.g. power andcontrol) is exterior to the subject. Therefore, the discussion herein ofan implantable device 30 will not be understood to eliminate selectedcomponents, such as a power source, stimulation reconnection, or otherfeatures or portions that may be placed in an external device forpercutaneous transmission through the lead assembly 34 to a stimulationlocation of the subject 62.

With continuing reference to FIG. 2, the ID 30 may be implanted in thesubject 32 in any appropriate location, such as in an abdominal wall, achest wall, sub-dermally near a clavicle, or other appropriatelocations. The lead assembly 34 may be connected to the ID 30 and passthrough selected tissue to a selected location for stimulation of thesubject 62. In various embodiments, as illustrated in FIG. 2, thestimulation lead assembly 34, including the first and second lead tipportions 40, 44 may be positioned in a lingual tissue (i.e. a tongue170). The lead assembly 34 may be positioned in the subject 62 along asingle path for a selected portion of the length of the lead assembly 34and/or may be immediately divided into two lead portions for positioningin the tongue 170. As one skilled in the art will understand, the tonguemay be formed of a plurality of muscle portions that may act in concertto cause movement of the tongue 170. Accordingly, reference to thetongue 170 is understood to refer to relevant portions of the tongue asdiscussed further herein. In addition, one skilled in the art willunderstand, the tongue 170 may include a plurality of nerve portions orconstructs, including those discussed further herein, including nerveends, endplates, etc.

With continuing reference to FIG. 2 and additional reference to FIG. 3and FIG. 4, the lead assembly 34 may be positioned at selected locationswithin the tongue 170. As illustrated in FIG. 2 and FIG. 3, the leadassembly 34 may include the first lead end or tip 40 and the second leadend or tip 44. Without being limited to the specific location of the twoleads 40, 44, the first lead tip 40 may be a left lead tip and thesecond lead tip 44 may be a right lead tip. Further, it is understood,that the two lead tips 40, 44 may be substantially identical to oneanother save for a specific position relative to the tongue 170 (e.g.right and left). Therefore, discussion of one or a single lead tip, suchas the lead tip 44, herein, is understood to be related to both leadtips unless specifically identified otherwise.

The tongue 170 may have branches of a hypoglossal nerve 176 therein. Thehypoglossal nerve 176 may extend from the seventh cranial nerve and intothe tongue 170. Natural, such as through signaling from the brain andspinal cord, innervation of the hypoglossal nerve 176 may cause movementor contraction of selected muscles in the tongue 170. The innervation ofthe hypoglossal nerve 176, therefore, may cause portions of the tongue170 to contract and/or stiffen.

As is generally understood by one skilled in the art, an obstructivesleep apnea (OSA) may occur when all or part of the tongue 170 falls orcollapses into the airway 180. Obstruction of the airway 180 may reduceor eliminate passage of air (e.g. including oxygen) to the subject 62.The obstruction may occur during a sleep cycle of the subject 62 and istherefore commonly referred to as OSA. A similar or related conditionmay be upper airway restrictive/resistance syndrome (UARS). Contractionof muscles in the tongue 170 may cause movement of the tongue 170 out ofthe airway 180 to reduce or treat OSA and/or UARS in the subject 62.

In some examples, an user (such as a surgeon) may implant the one ormore leads 40, 44 such that one or more electrodes 190, 194 areimplanted within soft tissue, such as musculature of the tongue 170,proximate to selected branches, such as medial branches, of one or bothhypoglossal nerves 176. In some examples, one or more electrodes 190,194 may be approximately 5 mm (e.g., about 2 mm to about 8 mm) from amajor trunk of the hypoglossal nerve 176. In some examples, one or moreelectrodes 190, 194 may be placed in an area of protrusor muscles of thetongue 170 that include motor points, where each nerve axon terminatesin the muscle (also called the neuro-muscular junction and/or nerve endplates). The motor points are not at one location but spread out in theprotrusor muscles of the tongue 170. Leads 40, 44 may be implanted suchthat one or more electrodes 190, 194 may be generally in the area of themotor points (e.g., such that the motor points are within about 1 mm toabout 10 mm from one or more electrodes 190, 194).

As described above, electrical stimulation therapy generated by IMD 30and delivered via one or more electrodes 190, 194 may activate protrusormuscles to move tongue 170 forward, for instance, to promote a reductionin obstruction or narrowing of the upper airway 180 during sleep. Asused herein, the term “activated” with regard to the electricalstimulation of protrusor muscles of the tongue 170 refers to electricalstimulation that causes depolarization or an action potential of thecells of the nerve (e.g., hypoglossal nerve(s)) innervating protrusormuscles of the tongue 170 and motor points and subsequent depolarizationand mechanical contraction of the protrusor muscle cells of protrusormuscles of the tongue 170. In some examples, protrusor muscles of thetongue 170 may be activated directly by the electrical stimulationtherapy.

In some examples, each one of electrodes 190, 194 may have equivalentelectrode lengths (e.g., longitudinal extend of electrodes 190, 194along lead body 40, 44). Lengths may be approximately 3 mm, but lessthan 3 mm lengths are possible. However, electrodes 190, 194 may haveelectrode lengths that are different from each other in order (e.g., tooptimize placement of the electrodes 190, 194 or the resultingelectrical field of stimulation relative to targeted stimulation sitescorresponding to left and right hypoglossal nerves or branches ofhypoglossal nerves and/or motor points of protrusor muscles of thetongue 170).

As illustrated in FIG. 3, the HG nerve 176 may include a left branch 176l and right branch 176 r. The first or left lead tip or end 40 may bepositioned on a left side of the tongue 170, which may be near the leftbranch 176 l. The second or right lead tip or end 44 may be positionedon a right side of the tongue 170, which may be near the right branch176 r. Thus, the two lead ends 40, 44 may be provided bi-laterally orspaced apart laterally from one another. As illustrated in FIG. 3, thelead ends 40, 44 may be spaced apart from one another and away from amid-lines of the tongue 170.

Providing the two lead tips 40, 44 to the tongue 170 may allow forselected stimulation pattern and/or bilateral stimulation within thetongue 170, as discussed further herein. Bilateral stimulation mayinclude selected subject benefits, as discussed herein. The stimulation,therefore, may be bilateral. As discussed herein, the bilateralstimulation may be provided to ensure or limit muscle fatigue, selectedtongue configuration, etc. Further, the bilateral stimulation mayalternate left and right and/or may be simultaneous both left and right.

The lead 40 may be positioned within the tongue 170 in any appropriatemanner, such as passing the lead 40 through a portion of the muscle ofthe tongue 170 and/or near nerve end plates. It is understood that thelead 40 and/or the lead tip 44 may be positioned near or adjacentselected nerves for stimulation of selected portions of the tongue 170.As illustrated in FIG. 3 and FIG. 4, the lead end 40 may include aplurality of electrodes or contact, such as four contacts 190, eachreferenced by a lowercase letter. It is understood that any appropriatenumber of contacts 190 n may be provided. Each of the electrodes orcontacts 190 may be connected to the power source 48 and controlledindividually and separately to provide stimulation to one or moreportions of the tongue 170 The stimulation through the electrodes 190may be provided in any appropriate manner, such as discussed furtherherein. In various embodiments, for example, one of the electrodes, suchas the electrode 190 a may be operated as an anode while a secondelectrode, such as the contact 190 b, may be operated as a cathode.Thus, a voltage differential may be generated between the two electrodes190 a and 190 b to provide stimulation to one or more portions of thetongue 170. As discussed above, stimulation of the HG nerve 176 maycause contraction of one or more portions of the muscle of the tongue170 and cause the tongue 170 to move out of the airway 180, at aselected time.

Briefly, the second lead tip 44 may also include one or more contacts,such as contacts 194, again each differentiated by a lowercase letter.It is understood that any appropriate number of contacts 194 n may beprovided. Again, each of the contacts 194 may be operated in a selectedmanner, such as selecting one to operate as an anode and another tooperate as a cathode.

The lead tips 40, 44 may be operated in concert or together such that alead electrode on the first lead tip 40, such as the electrode 190 a maybe operated as an anode and a second electrode, such as the electrode194 a on the second lead tip 44 is operated as a cathode. Thus,stimulation may be provided across the tongue 170 between the two leadtips 40, 44 (e.g. spaced apart on the tongue 170) and/or on a singleside (e.g. along one side of the tongue 170) such as between theindividual lead tips 40, 44. As also discussed further herein, thestimulation of the tongue 170 may be operated to be in a unilateraland/or bilateral manner. For example, the left side of the tongue may bestimulated with the first lead tip 40, followed by the right side of thetongue being stimulated by the second lead tip 44, followed bystimulation between the two lead tips 40, 44. It is also understood thatvarious other possible stimulation anodes or techniques may also beprovided, as also discussed further herein.

With continuing reference to FIGS. 3 and 4, the lead tips 40, 44 may bepositioned in an appropriate portion of the tongue 170. Therefore, thelead tip 40 may be positioned substantially near an inferior portion ofthe tongue 170, such as near a bony portion of a mandible or lower jaw198 and/or a fat or cutaneous layer 200 of the subject 62. Stimulationof one or more portions of the tongue 17076 has been discovered to causecontraction of selected muscle portions of the tongue 170 to cause thetongue tissue to move from or out of the airway 180 so as to open theairway 180 and remove an obstruction due to relaxation or movement ofthe tongue 170 into the airway 180.

In various embodiments, and without being limited to the theory, aselected position of the tongue may be that of an awake subject havingan open airway for breathing without their tongue protruding from themouth. Generally, to alleviate OSA with the stimulation therapy, theobjective is to open or enlarge the upper airway. In variousembodiments, this may stiffen the upper airway to prevent collapseduring inspiration. This may occur through the stiffening of secondarymuscles caused by stretching of those muscles when the primary muscle isstimulated and contracts. In addition, muscle contraction could occur bymeans of a centrally mediated reflex (i.e. a neural sensing signal issent to the central nervous system which causes muscle contraction inthe upper airway.

The stimulation system 20, including the stimulator portion or assembly24, is provided to selectively stimulate portions of the subject 62, asdiscussed above. The stimulation of the subject 62 may be providedthrough the lead tips 40, 44 in a selected manner, such as bilaterally,unilaterally, switching unilaterally, and between the plurality ofcontacts 190, 194 of the respective lead tips 40, 44. With reference toFIGS. 5A through 5G, various types of stimulation may be provided to thetongue 170 via the lead assembly 34. The stimulation may be to one ormore portions of the tongue 170 to cause activation of one or moreselected muscle groups or portions. The activation of the muscle, suchas due to the stimulation from the system 20, may cause contraction(including stiffening) of the muscle portions. Thus, stimulation of oneor more selected one or more portions of the tongue 170 and/or nerveand/or nerve endplates may lead to activation of one or more musclegroups or portions.

The stimulation to one or more portions of the tongue 170 may beprovided in a bilateral manner, such as to the left branch 176 l and theright branch 176 r. In a bilateral stimulation, the stimulation may beprovided to both branches 176 l, 176 r simultaneously, alternatingbetween the two branches, with a gap between the bilateral stimulationand/or with no gap. Further, the magnitude of stimulation in a bilateralmanner may be the same or different and may vary over time. Variousexemplary stimulation patterns are discussed and illustrated here. Thebilateral stimulation may also cause bilateral (including simultaneousand/or bilateral alternating) activation of muscle groups in the tongue170.

The various patterns, in various embodiments, may be provided forproviding a non-continuous stimulation to at least selected portions,including the entirety, of the tongue 170. Nevertheless, even ifnon-continuous stimulation is provided to a particular portion or regionof the tongue 170, a selected bilateral stimulation may allow forsubstantially continuous stimulation to at least selected portions ofthe tongue 170. Thus, the tongue 170 may be non-continuously stimulated,stimulated in a continuous manner bilaterally, or continuouslystimulated in an alternating bilateral manner, or combinations thereof.

As illustrated herein, each of the lead ends 40, 44 may be operated forselected duty cycles. In various embodiments, the stimulation fromeither of t lead ends 40, 44 may be pulsed. The pulses may repeat, asdiscussed herein. The stimulation waveforms as illustrated in FIGS.5A-5G may illustrated the duty system and have periods appropriate forproviding therapy to the subject 62. Further, the stimulation may beprovided at a selected magnitude form the ID 30. The magnitudes mayrefer to a selected frequency of provided during the on duty cycle (e.g.10 Hz to about 200 Hz, including about 20 Hz to about 80 Hz), voltage(e.g. about 0.1 volts to about 15 volts, including about 0.1 volts toabout 5 volts), amperage (e.g. about 0.1 milliamps to about 20milliamps, including about 0.1 milliamps to about 15 milliamps). Ramp upand ramp down, as discussed herein, may include a gradual or selectedincrease or decrease of the above noted magnitudes.

With initial reference to FIG. 5A, stimulation may be provided asillustrated on the graph 220. The graph 220 illustrates two axes,including a magnitude y-axis 224 and a time x-axis 228. It is understoodthat the magnitude may be any appropriate magnitude including voltage,current, or the like. Further, the magnitude of stimulation may be basedupon a selected subject and may be determined or learned from a specificsubject and/or group of subjects (e.g. a group or population of subjectswith similar characteristics). Accordingly, the graph of the stimulationis relative and may be provided for a specific subject based uponspecific values therefor.

With continuing reference to FIG. 5A, the stimulation graph 220 mayinclude a left stimulation portion 230 (i.e. provided with the left lead40) and a right stimulation portion 234 (i.e. provided with the rightlead 44). Each of the stimulation portions may each include respectiveramp up phases 230 a, 234 a, a peak or selected stimulation 230 b, 234b, and a ramp down phase 230 c, 234 c. The ramp up phases 230 a, 234 aand the ramp down phases 230 c and 234 c may be increasing or decreasingover time. In various embodiments, however, a ramp up or down may not beprovided and the waves, therefore, may be substantially square.Accordingly, the ramp up and ramp down phase includes a varyingmagnitude over time and is merely exemplary. Ramp up and down, however,may be provided for subject comport, selected stimulation or contractionproperties, etc.

The right and left stimulation portions 230, 234 may be initiated andthen stopped to achieve a maximum stimulation 230 b, 234 b. Further thestimulation portions 230, 234 may be provided in a substantiallyrepeating manner over a selected period of time, as discussed furtherherein. Accordingly, a repeating ellipsis symbol 240, may indicate thata repetition of the stimulation portions 230, 234 over a selected periodor a selected time.

The stimulation portions including the left stimulation 230 and theright stimulation 234 may be separated by a selected time gap or timeportion 244. Accordingly, the left stimulation portion 230 may stimulateor be caused to provide stimulation to only the left portion of thetongue 170 for a selected period of time, such as about 1 second. Thestimulation of 1 second may be inclusive of the ramp up 230 a and theramp down 230 c. Nevertheless, it is further understood that thestimulation of the left portion 230 may be any appropriate time and 1second is exemplary for the current discussion. Similarly, the rightstimulation portion 234 may be used to cause stimulation of only theright portion of the tongue 170 for a similar or substantially equaltime, such as about 1 second. The left and right stimulations may beprovided to only the left or right portion of the tongue 170 when therespective lead ends 40, 44 are operated to stimulate the one or moreportions of the tongue 170.

As illustrated in the graph 220 the right stimulation portion and theleft stimulation portion do not overlap and may be spaced apart from oneanother by a selected period of time, such as by the time gap 244. Thetime gap 244 may be an appropriate time, such as about 0.25 seconds. Itis understood, however, that the time gap may be any appropriate timegap. In various embodiments, the time gap 244 may be provided to ensurea relaxation of the tongue 170 a selected amount, or to ensure adissipation of the stimulation from either of the right or leftstimulation lead tips 40, 44. Thus, the stimulation gap 244 may be about0.25 seconds to about 0.75 seconds, and further including about 0.5seconds.

Regardless of the length of the right or left stimulation portions 230,234, the ramp up or ramp down times, or other features of the right andleft stimulations, the stimulation gap 244 may separate stimulation on aright and left side of the tongue 170. Thus, the left lead 40 may becaused to stimulate only a left portion of the tongue 170 for a selectedperiod of time, stimulation may then be stopped to the left stimulationlead 40 for a selected period of time (i.e. the stimulation gap 244),and stimulation may then be initiated by the right lead 44 for aselected period of time to stimulate only the right side. Thus,effectively, only one side of the tongue 170 is stimulated at a time. Asdiscussed above, the stimulation pattern may then be repeated for aselected period to stimulate the tongue 170.

Turning reference to FIG. 5B, a graph 250 is illustrated. The graph 250is similar to the graph 220, discussed above, and will not be discussedin detail separate from the stimulation portions, which include a leftstimulation portion 254, illustrated in solid line, which may repeat,including a repeating portion 254′. Further, a right stimulation 258 isillustrated in dash line. Similarly, as discussed above, the simulationpattern may repeat including the portion illustrated in FIG. 5B along arepeating section or portion 262. Each of the stimulation portions 254,258 may include ramp up, peak, and ramp down portions, similar to thosediscussed above. Accordingly, the individual portions will not bediscussed as they are similar to those discussed in FIG. 5A.

The stimulation portion or sections, however, as illustrated in FIG. 5B,may be for a selected period of time, such as the first left stimulationportion may stimulate between a time zero and a time two. In variousembodiments the time elapsed between zero and two may be any appropriatetime, such as about 1 second, as discussed above. The right stimulation258, however, may initiate or start at a selected time, such as a timeone. The time one may be a selected time between time zero and time two.For example, the time passage or lapse between time zero and time onemay be about 0.5 seconds. Therefore, the left stimulation 254 may be onfor about 1 second and about half way through the right stimulation 258may initiate. The stimulation of the left and the right, therefore, mayhave an overlap 266 of a selected time, such as about 0.5 seconds. Thus,while the left electrode 40 is being powered to stimulate the leftportion of the tongue 170, the right electrode 44 may be initiated tostimulate the right portion of the tongue 170 simultaneously.

This allows the stimulation in the tongue 170 to be bilateral, however,include a selected simultaneous overlap 266. The overlap may occur atany appropriate time, such that the ramp up of the right stimulation 258occurs so that the peak occurs as the left stimulation begins to rampdown. It is understood, however, that other appropriate overlaps may beprovided and again the particular length of overlap may be differentbased upon a selected subject. Nevertheless, it is understood that thestimulation system 24 may provide stimulation that overlaps, asillustrated in FIG. 5B and/or includes a time gap, as illustrated inFIG. 5A.

Turning reference to FIG. 5C, a graph 280 is illustrated. The graph 280may include axes similar to those discussed above and, therefore, willnot be repeated in detail here. As illustrated in the graph 280, a leftstimulation 284 and a right stimulation 288 is illustrated. Again theleft and right stimulations 284, 288 may include selected ramp up andramp down and peak periods, as illustrated in the graph 280, are notrepeated in detail here as they are similar to those discussed above.

The left stimulation 284 may stimulate from a time zero to a time one.The right stimulation may stimulate from the time one to a time three.As discussed above, the left stimulation 284 and the right stimulation288 may be separated by a selected time gap 244 and/or include aselected overlap 266. It is further understood that the rightstimulation 288 may begin immediately during a pause or ending of theleft stimulation 284 and/or vice versa. Similarly the pattern of theleft and right stimulation 284, 288 may repeat 292 for a selected time.

As illustrated in FIG. 5C, the left stimulation 284 may have a lengthone, which may be any appropriate time span, such as 1 second. The rightstimulation 288 may include a selected time span such as two, which maybe any appropriate time span, such as 2 seconds. Therefore, it isunderstood that the left and right stimulation periods may be differentperiods, such as one being twice as long than the other. It is furtherunderstood that the variance in times may alternate and/or be reversedsuch that the left stimulation 284 may be longer than the rightstimulation 288. In this manner, the left and right stimulations 284,288 may provide stimulations for different lengths of time to theselected portions of the tongue, such as the left HG branch 176 l andthe right HG branch 176 r. Thus, the tongue 170 may be stimulatedaccording to differing time lengths on the right and left side.

Turning reference to FIG. 5D a graph 300 is illustrated. Again, thegraph 300 may be similar to the graphs discussed above, and will not bediscussed in detail. As illustrated in the graph 300 a left stimulation304 and a right stimulation 308 are illustrated. As discussed above, thestimulations may have the gap 244 between them, the overlap 266, or maybe substantially start and stop when the other respectively starts orstops. Further the pattern may repeat as illustrated by the repeatsymbol 312.

The left and right stimulations 304, 308, may further include differentpeak magnitudes. As illustrated in FIG. 5D, the left stimulation peak304 a may have a magnitude of two. The peak of the right stimulation 308a may, however, have a different magnitude, such as a magnitude of one.It is understood that the magnitude of one and the magnitude of two mayrepresent any appropriate magnitude, such as the magnitude of one beingabout 1 volt and the magnitude of two being about 2 volts. Thestimulation magnitude, however, may also refer to other magnitude valuessuch as an electrical current. Nevertheless, the left and right peaks304 a, 308 a may be different from one another. It is further understoodthat the magnitude of the left stimulation 304 a may be less than themagnitude of the right stimulation 308 a, and vice versa. Further, asdiscussed above, the magnitude may be different from one another and mayalso alternate in magnitude. Accordingly, after a selected period oftime the left magnitude 304 a may be less than the right magnitude 308 aand may also switch back.

Turning reference to FIG. 5E, a graph 320 is illustrated. Again thegraph 320 may be similar to the graph discussed above, and details willnot be discussed here. Illustrated in the graph 320 is a leftstimulation 324 and a right stimulation 328. The left stimulation 324includes a peak stimulation magnitude 324 a and the left stimulationincludes a peak 328 a. The peak stimulations may be of the samemagnitude, or different magnitudes, as discussed above. Further the leftand right stimulations 324, 328 may overlap, have a gap therebetween, orimmediately follow after one another. The stimulation pattern may repeatin the stimulation repeat 330.

The left stimulation 324 may include a ramp up 324 b and a ramp down 324c. Similarly the right stimulation 328 may include a right ramp up 328 band a ramp down 328 c. The left stimulation 324 may begin at time zeroand end at time two. The ramp up 324 b may extend between time zero andtime 0.75 and the ramp down may extend between time 1.25 and 2.Accordingly, the ramp up and ramp down 324 b, 324 c may have time lapsesof about 0.75. It is understood that the time lapses may be anyappropriate time, and may include time lapses of about 0.75 seconds,each.

The right stimulation 328 may begin at time two and have a ramp up untiltime 2.25. The ramp down 328 c may have a ramp down time 2.75 to timethree. Accordingly, the ramp up 328 b and the ramp down 328 c may havetime lapses of about 0.25. It is understood that the lapsed time may beany appropriate time, and 0.25 seconds is merely exemplary.Nevertheless, the ramp up and ramp down of the right stimulation 328 maybe about 0.25 seconds, while the ramp up and ramp down 324 b, 324 c ofthe left stimulation 324 may be about 0.75 seconds. The time of the peakstimulation for the left and right stimulating peaks 324, 328 may besubstantially similar or identical, however, the ramp up and ramp downtimes may be different. It is also understood, however, that the peaktimes may also be different, include different amplitudes or magnitudes,or also otherwise different. Nevertheless, it is understood that theramp up and ramp down times may differ in length and slope, asillustrated in FIG. 5E.

Turning reference to FIG. 5F, a graph 350 is illustrated. Again thegraph 350 may include portions that are similar to those discussedabove, and will not be repeated here. Further, the graph 350 illustratesa left stimulation 354 in solid lines and a right stimulation 358 indash lines. Further the stimulation pattern may repeat as illustrated bythe repeat 362. Again, it is understood, that the left stimulation 354and the right stimulation 358 may include various features, such asthose discussed above, including the gap 244, the overlap 266, a startand stop that are substantially simultaneous, and the like.

The graph 350 illustrates that the left and right stimulations 354, 358may alternate between a maximum or peak stimulation 354 a, 358 a and aminimum stimulation 354 b and 358 b. The maximum stimulation 354 a, 358a may be any appropriate magnitude, and may be substantially selected tobe the same for both the left and right stimulations 354, 358. Invarious embodiments, the maximum or peak stimulation 354 a, 358 a may bea magnitude of two. The minimum stimulation 354 b, 358 b may be aselected magnitude such as a magnitude of one. Again as understood thatthe left and right stimulations 354, 358 may have respectively differentmaximum and minimum stimulations and the illustration of a minimum ofone and a maximum of two is merely exemplary. Nevertheless, asillustrated in the graph 350, the minimum stimulation 354 b, 358 b neednot be zero. As illustrated and discussed above, the stimulations mayvary between zero and some selected magnitude. It is understood,however, that the stimulations may not return to zero during a selectedstimulation period. Accordingly, during stimulation the left stimulationmay alternate between one and two, after stimulation has begun, and theright stimulation 358 may also alternate between a magnitude of one andtwo. The stimulation provided to the tongue 170, through both of theelectrode tips 40, 44, need not ever be zero during a stimulationperiod. Although the stimulation from either or both of the electrodetips 40, 44, may alternate and increase and decrease over time, thestimulation from either of the electrode tips need not be zero. Thus abilateral continual stimulation may occur even if it varies over time.

Turing to FIG. 5G, a graph 380 is illustrated. The graph 380 includesportions similar to those discussed above and will not be repeated indetail here. The graph 380 further includes a left stimulation waveform384 illustrated in solid line, and a left simulation waveform 388illustrated in dash line. As illustrated in FIG. 5G, the left simulationmay be substantially sinusoidal between a magnitude of zero and amagnitude of two. Similarly the right stimulation 388 may alternatebetween a minimum 388 a of zero and a maximum of 388 b of two. The leftand right curves 384, 388, as illustrated in FIG. 5G, may alternate in asinusoidal fashion or manner and may cross at any selected value, suchas a value magnitude of one.

The frequency, amplitude, and phase of the respective stimulation waves384, 388 may be varied to provide a selected stimulation to the subject62 similar to that discussed above. As illustrated in FIG. 5G, theintersection of the left and right stimulations 384, 388 may be in themagnitude of one, such that there is never a magnitude of zerostimulation to the tongue 170. It is understood, however, that therespective curves 384, 388 may be moved such that the stimulation may goto zero from both of the leads 40, 44 at a selected time and/or for aselected period of time. Nevertheless, the stimulation from the left andright leads 40, 44 may vary over time being a sinusoidal wave ratherthan a straight ramp up and ramp down and/or square wave, as discussedabove. Thus, the peak stimulation may be provided for only a smallamount of time and the stimulation is substantially constantly varyingto either or both of the lead tips 40, 44. Further, as discussed above,the respective stimulation curves 384, 388 may repeat for a selectedperiod of time 390.

With continuing reference to FIGS. 5A-5G, stimulation patterns from theID 30 may be provided to the electrode tips 40, 44 in a plurality ofwaveforms, as discussed above. Further, as illustrated in FIG. 5F, thestimulation magnitude may never reach zero. However, the minimumstimulation, as illustrated to be one, may be an amount provided to ator just below (e.g. about 0.1 volts to about 15 volts) to causestimulation and/or contraction of a selected muscle. Accordingly, whilethe magnitude may not be zero for the stimulation, the stimulationmagnitude value may be that causes no activation of a selected muscle.Thus, the waveform of stimulation may be between a stimulation valuethat does not stimulate or cause contraction of muscle to a value thatcauses a selected contraction of the muscle.

Further, as discussed above, the waveforms of any of the selectedwaveforms may include a substantially square wave, where a ramp up issubstantially instantaneous between a zero or selected minimumstimulation and the peak value of stimulation. The waveform forstimulation, however, may also be sinusoidal, sawtooth, triangular, etc.It is understood that the waveforms may be an appropriate form shapeselected to stimulate the selected subject 52.

Further, as illustrate above, the right and left stimulation waveformsmay be out of phase with one another. Thus, stimulation may be providedwith only the left lead end 40 or the right lead end 44. The phase ofthe two waveforms am also include some overlap, but not entirely inphase.

With continuing reference to FIG. 3 and FIG. 4, and additional referenceto FIGS. 6A-6C, stimulation with the selected electrode leads 34 mayinclude stimulation between the two lead tips 40, 44, stimulationbetween the various electrodes on the respective tips 40, 44, in variouspatterns. Various exemplary patterns are discussed here, and exemplaryillustrated in FIGS. 6A-6C, to illustrated various exemplary patterns.Initially, the two lead ends 40, 44 may be positioned contra-laterallyin the tongue 170. In other words, the left lead end 40 may be placednear the left portion of the tongue 170 and the right lead end 44 may beplaced near the right portion of the tongue 170. The lead ends 40, 44,therefore, may be spaced laterally from one another. The lead ends 40,44, however, may be operated to provide bilateral stimulation such thatthe right and left sides of the tongue may be stimulated. In variousembodiments, the bilateral stimulation may be simultaneous such thatboth sides are stimulated at the same time.

As discussed above, various waveforms or stimulations sequences may beused to stimulate the one or more portions of the tongue 170. Inaddition to the various waveforms, the electrodes may be operated in avarious manners to provide simulation to selected areas and/or selectedsimulation volumes within the tongue 10. As illustrated in FIG. 6A, theelectrode tips 40, 44 are placed contra-laterally in the tongue 170.Each of the electrodes 40, 44 include a plurality of electrode pads orcontacts 192, 194, respectively.

In various embodiments, for example, the first electrode contact 192 amay act as a cathode and the fourth electrode contact 192 d may act asan anode to cause a voltage therebetween. In various embodiments,therefore, the voltage or current 400 therebetween may stimulate an areabetween the first electrode contact 192 a and the fourth contactelectrode 192 d. Similarly, the electrode contact 194 a may act as ananode and the fourth contact 194 d may act as a cathode and a voltage404 may be generated therebetween.

The left electrode tip 40 may be operated substantially separately fromthe right electrode tip 44, in various formats as discussed above. Thesimulation may be between the two electrode contacts 192 a and 192 d andin series or sequentially with the contacts 194 a, 194 d. Thus,stimulation will not flow between the two electrode tips 40, 44, butonly between the selected electrodes and the selected electrode tips.Further a left stimulation may be only stimulating between the twoelectrode contacts 192 a, 192 d of the left electrode tip 40 andstimulation between the electrode contacts 194 a, 194 d of the rightelectrode. This allows stimulation to be provided bilaterally in series,continuously, or in any appropriate manner, as discussed above to theselected waveforms.

Turning reference to FIG. 6B, the left and right lead tips or ends 40,44 are positioned in the tongue 170, as discussed above. The lead tips40, 44 include the respective electrode contacts 192, 194, as alsodiscussed above. The contacts may be used to provide varying ordifferent stimulation to the one or more portions of the tongue 170, inaddition to that illustrated in FIG. 6A. For example, the left lead tip40 may provide a stimulation between the two contacts 192 a and 192 b,such as at a first time the first contact 192 a having an anode and thesecond contact 192 b may be a cathode. It is understood that these maybe alternated or reversed, in various embodiments. Further, at a secondtime the second contact 192 b may provide a stimulation 414 between thesecond contact 192 b and the fourth contact 192 d. Therefore, at a firsttime, stimulation may be provided between the first and second contacts192 a, 192 b, and at a second time a stimulation may be provided betweenthe second contact 192 b and the fourth contact 192 d.

At a third time, for the right electrode tip 44, stimulation may beprovided between the first contact 194 a and the second contact 194 b.The stimulation 418 may be with the first contact 194 a being an anodeor a cathode and a second contact 194 b being the opposite thereof. At afourth time stimulation may be provided between the second contact 194 band the fourth contact 194 d. The stimulation 420 may be the secondcontact 194 b being an anode or a cathode and the fourth contact 194 dbeing the opposite thereof.

In various embodiments, therefore, the different contacts 192, 194 maybe operated as anodes or cathodes to provide stimulation at selectedareas. For example, an area stimulated by the first stimulation portion410 or the third stimulation portion 418 may be proximal along the leadtips 40, 44, while the second four simulations 414, 420 may be moredistal. In various embodiments, stimulating different areas may achievedifferent results relative to the subject 62.

Further, the different stimulations 410, 414, 418, 420, may be providedat different times, as discussed further herein. For example, the leftelectrode tip 410 may cause the stimulation 410 at a first time, whichis then followed by the stimulation 420 by the right electrode tip 44,which is then followed by any other appropriate stimulation, such as thestimulation 414 with the left electrode tip 40 and/or the rightstimulation tip 44 causing the stimulation 418. Further, bilateral orsimultaneous stimulation of both the left and right electrode tips 40,44 may be caused at different positions such as a simultaneousstimulation with the stimulation 410 and the stimulation 420 with therespective left and right electrode tips 40, 44.

Turning reference to FIG. 6C the left and right electrode tips 40, 44may be positioned within the tongue 170, as discussed above. Therespective electrode tips or ends 40, 44 include the respectiveelectrodes 192, 194, as discussed above. The stimulation may beprovided, according to various embodiments, between the separated leftand right electrodes 40, 44. For example, the first electrode 192 a ofthe left electrode tip 44 may provide a stimulation path with the firstelectrode 194 a of the right electrode tip 44 along a stimulation path430. Thus, stimulation may occur between the left and right lead tips40, 44.

As a further example, stimulation may occur between electrode contactsat different contacts along the length of the electrode or lead tips 40,44. For example, stimulation may occur between the second electrodecontact 192 b and the fourth electrode contact 194 d. The stimulationpath 434 may allow for stimulation between two levels or at varyingdistances relative to a proximal position of the electrode leads 40, 44within the subject 62. Thus, stimulation may be provided across thetongue 170 between the two separated lead ends 40, 44.

With reference to FIGS. 6A-6C, stimulation may be provided betweenvarious electrodes of the electrode lead tips 40, 44, at various times.It is understood that the stimulation pattern may occur or change overtime, such as based upon a programming of the ID 30. Thus, the subject62 may be stimulated in an appropriate physical location, and theillustrations or examples in FIGS. 6A-6D are merely exemplary. It isunderstood that stimulation may be provided between any selectedelectrodes of the electrode lead tips 40, 44 and the above are merelyexemplary regarding the stimulation between different electrode contacts192, 194 of the respective lead tips 40, 44, and/or between theelectrode lead tips 40, 44.

As illustrated in FIGS. 6A-6C the lead ends 40, 44 that are placed indifferent locations within the tongue may be operated to stimulateddifferent areas within the tongue 170. The electrodes 190, 194 of therespective lead ends 40, 44 may be used to stimulated separated anddifferent physical locations of the tongue. Different physical locationsmay provide differing efficacy of treatment for OSA and/or UARS.

With additional reference to FIGS. 5A-5G, stimulation from the ID 30 tothe subject 62 may also occur according to selected pulses and/or wavesthat various stimulation of the subject 62. The various stimulation wavepatterns, as illustrated in FIGS. 5A-5G, are also understood by oneskilled in the art to be merely exemplary. The wave patterns may allowfor stimulation of the subject according to various magnitudes, timedifferentials, and differentials between a left and right electrodepositions. It is also understood that more than two electrode tips maybe positioned in the subject such that an additional or third and/or anyappropriate number of electrode positions may be determined or placed.

With reference to FIGS. 5A-5G and FIGS. 6A-6C, the subject 62,therefore, may be stimulated in a manner to reduce or eliminate musclefatigue over an extended stimulation therapy. The reduced fatigue mayincrease an efficacy of treatment and/or achieve a threshold of efficacyor result parameters. For example, the waveform of stimulation may bealtered or changed or waveform may alternate in a selected pattern ordifferential to ensure that a continuous stimulation at a singlemagnitude is not maintained. Thus, the stimulation may be discontinuousand allow for a period of relaxation of the muscle of the subject sothat the muscle does not fatigue and no longer respond to thestimulation therapy. Further the physical location of the therapy maydiffer over time, as exemplary illustrated in FIGS. 6A-6C, to alsoassist in reducing or eliminating muscle fatigue. The fatigue of amuscle may occur when a single muscle and/or single area of a muscle isstimulated for an extended period of time. After the extended period ofstimulation the muscle may no longer react or fail to contract in aselected manner. Therefore allowing a muscle to relax allows for a moreand/or predictable response to a stimulation from the ID 30.

In various embodiments, therefore, as discussed further herein,stimulation may be provided to the subject 62 in a selected manner tosubstantially reduce and/or eliminate muscle fatigue. Reduction and/orelimination of muscle fatigue can allow for a selected result and/oroptimal result for a selected subject 62. As discussed above,stimulation of one or more portions of the tongue 170 may causeactivation (e.g. contraction) of selected muscles of the lingual muscleor tongue 170 to assist in treating OAS and/or UARS.

As discussed above, the stimulation may be provided to the subject 62,particularly in the tongue, for alleviating various conditions and/orproviding therapy to the subject 62. The therapy may be provided to thesubject according to selected electrode stimulation patterns, wavepatterns for stimulation, and other features or treatment types ormagnitudes. As discussed further herein, the therapy may be delivered tothe subject 62 in an appropriate manner that may be based upon variousfactors and/or inputs from various sensors, the subject 62, a clinician,or other appropriate inputs. The therapy may be provided by the ID 30based upon programming stored in the memory thereof, from the CTM 70,74, or other appropriate processor. In various embodiments, the therapymay be provided based upon a set or selected set of instructions, aselection from a plurality of a set of instructions, and/or an adaptiveor learning algorithm (e.g. machine learning algorithm or system) toprovide a selected or optimal therapy for the subject 62.

The stimulation system 20 may include the ID 30 that provides energy tothe stimulating lead tips 40, 44 according to the appropriate patternsand configurations, as discussed above. In addition to the CTM's 70, 74,the input sensors 61, 61′ may provide input to the ID 30 and/or theCTM's 70, 74. As discussed above, the sensors 61, 61′ may provideinformation regarding the subject 62 including various oxygen saturationamounts (arterial or tissue oxygenation saturation amounts), muscleactivation (e.g. electromyography (EMG)), temperature, body position(e.g. using an accelerometer), cardiac rhythm (electrocardiograph(ECG)), or other appropriate sensors. As is generally understood by oneskilled in the art, a sleep study may be performed on the patient whichincludes sensing various features of the subject 62 in a polysomnograph.One or more of the sensed elements of the subject 62 may be sensed withthe sensors 61, 61′ to assist in providing an appropriate stimulation tothe subject 62 as a part of the therapy provided to the subject 62.

Accordingly, with reference to FIG. 7 and continuing reference to FIGS.1-6C, a process or a system flowchart 480 is illustrated. The process480 may be executed by the processor module 50 in the ID 30, and/or theprocessor modules in either the first or second CTM 70, 74 viatransmission of a signal to the ID 30. Accordingly, the process 480 maybe used to provide a selected therapy to the subject 62, in a selectedmanner, as discussed above. Initially, the process 480 may begin instart block 484. The process starting in block 484 may be anyappropriate start, such as powering the ID 30 on, implantation of the ID30, or the like. Once the process is started in block 484, adetermination of whether stimulation should be initiated may be made inblock 500.

Initiating of stimulation may be based upon various inputs such as adetermination of a proximity to one or more of the CTM's 70, 74. Forexample, the first CTM 70 may be positioned near a subject sleepingorientation and/or powered on or initiated by the subject 62 at thebeginning of a sleep cycle. Therefore, proximity to the CTM 70 and/orreceiving a signal from the CTM 70 may be provided to initiatestimulation in block 500. Further, as discussed above, various inputsfrom sensors, such as the sensor 61 or the external sensor 61′ may beused to determine whether initiation of stimulation may occur. Forexample, position of the subject 62 may be used to determine that thesubject 62 is in a laying position or horizontal position. Thus, theinitiation of stimulation or stimulation process may be based upon theposition of the subject. Regardless, initiation of stimulation may bedetermined in block 500.

If it is determined that initiation of stimulation should not occur, aNO path 504 may be followed. The NO path 504 may return to the startblock 484. In various embodiments, for example, the determination ofwhether initiation of stimulation should occur in block 500 may be basedupon a selected periodic cycle of the ID 30. In various embodiments, forexample, a low power clock or timer may be included in the ID 30. Thetimer may be set for a selected period of time (e.g. 10 minutes).Accordingly, the start block 484 may be initiated every 10 minutes ifthe ID 30 is not already in a stimulation cycle. It is understood,however, that the start block 484 may be entered in any appropriatemanner.

If initiation of stimulation is determined in block 500, a YES path 510may be followed. The YES path 510 may go or follow to detect or sense asensor signal in block 520. The detection of a sensor signal in block520 may be an input from a sensor sensing any appropriate feature of thesubject 62. For example, measuring of an arterial oxygen saturation(SPO2) may be made and/or the measurement of a tissue oxygen saturation(STO2). The oxygen saturation may be measured in any appropriatelocation, such as at the ID 30, with an external measuring device, or atany position along the lead 34. Regardless the sensor may provide aselected oxygenation saturation to the processor, such as the IDprocessor 50.

Other sensor information may be related to the EMG. The EMG may besensed at the lead contact at the lead tips 40, 44. In variousembodiments, for example, a chin EMG may be measured using the tipelectrodes 40, 44. The EMG may be a time average signal (e.g. an EMGaveraged over a selected period of time, such as 10 seconds).Regardless, the EMG may be sensed and analyzed for determination of astimulation, as discussed further herein.

As discussed above, the subject 62 may have undergone a sleep study at aselected period of time, such as prior to implantation of the ID 30. Thesleep study of the subject 62 may be used to determine various selectedthreshold values of sensed information of the subject 62. As discussedfurther herein, selected population values may be determined for sensedinformation such as oxygen saturation, EMG signal values, and the like.Regardless of the timing of the determination and/or source of thedetermination, the memory 54, and/or any appropriate memory, such as thememory 102 of the CTM 70, may be used to store for recall the selectedvalues.

The calibration and/or recall of the selected sensor information can bemade at any appropriate time, such as at an initial implantation of theID 30, during a sleep study of the patient 62, or after initialimplantation and use of the ID 30 after a selected number of sleepcycles with the ID 30 in the subject 62. Regardless, the appropriate orselected sensory levels or values may be determined and/or stored on thememory 54 for recall by the processor 50 of the ID 30.

The selected processor module, such as the processor module 50 of the ID30, may then compare the detected sensor signal from block 520 and thecalibrated or recalled value from block 538 in block 540. The comparisonin block 540 may be based upon the selected sensor signal from block 520compared to the recalled signal or value in block 538. The comparisonmay then be used to determine whether stimulation may be provided orshould be provided to the subject 62, such as based upon the calibratedor determined value in block 538.

The calibrated signal may be based upon or used to determine a thresholdvalue for one or more of the sensed values, such as an oxygenationvalue, EMG value, or the like. Accordingly, once the comparison is madein block 540, a determination of whether the sensor signal from block520 is at a threshold or selected value when compared to the calibratedvalue is made in block 538. The determination is made in block 544. Thecomparison may be made by the processor module 50 in the ID 30 todetermine whether a stimulation should be delivered to the subject 62.

The determination of whether the sensor signal is equal to or greaterthan a threshold in block 544 may then be made to follow a selectedpath. If a sensor signal from block 520, when compared in block 540, isequal to or greater than a threshold value, a YES path 550 may befollowed. The YES path 550 may follow or allow for a determination thatstimulation should not be on, therefore a stimulation off 556 isfollowed. The stimulation off in block 556 may be made to determine thatno stimulation should be provided through the selected electrode leads34. Accordingly, no stimulation or a stimulation off may includesensation or stopping of a previous stimulation or not initiatingstimulation through the leads 34.

After a determination that a stimulation should be off in block 586 acheck or recheck of whether stimulation should be initiated may be madein block 562. The rechecking or checking of initiation of a stimulationin block 562 may return to the initiation stimulation in block 500.Accordingly, it is understood that the process 480 may be a loop processonce the ID 30 is started or implanted in block 584. Accordingly, theinitiation of the stimulation in block 500 may continue through thevarious steps to the determination of whether the sensor signal is equalto or greater than a threshold in block 544, as discussed above.

Therefore, a determination of whether the sensor signal is equal to orgreater than a threshold in block 544 may also follow a NO path in block570. Once following the NO path in block 570, a determination or recallof stimulation pattern or properties is made in block 574.

The stimulation pattern or properties may be any appropriate stimulationpattern or properties, as discussed above. The pattern may bepreprogrammed in the memory 54 of the ID 30 at any appropriate time,such as based upon a sleep study of the subject 62, a learning basedupon a selected learning algorithm, as discussed further herein, orother appropriate determination. Regardless, a recall or determinationof a stimulation pattern may be made in block 574 to stimulate thesubject 62.

After a recall or determination of a stimulation pattern or property inblock 574, the stimulation may be turned on or started in block 578. Asdiscussed above, the stimulation may not be provided from the ID 30 tothe subject 62 through the leads 34 until a selected determination ismade, such as the determination in block 544. Accordingly, once thedetermination is made that a threshold value of a selected sensor inputis not made in block 544, the NO path 570 is followed and adetermination or recall of the stimulation pattern in block 574 is made.The stimulation recalled in block 574 may then be initiated or startedin block 578 to stimulate the subject 62 according to a determined orselected stimulation pattern.

After starting stimulation, the subject 62 may be stimulated for anappropriate period of time (e.g. one selected in the determinedstimulation pattern). Once the selected stimulation occurs in block 578a check or recheck of when initiation of stimulation should be made inblock 562 may occur. Accordingly, even after a stimulation occurs inblock 578, a recheck or loop of the stimulation determination may bemade according to the process 480. Thus, the process 480 may besubstantially continuous or a loop process to provide stimulation to thesubject 62 as needed and/or determined to provide an appropriate therapyto the subject 62.

The process 480 may allow for a stimulating or not stimulating thesubject 62. The process 480 may loop an appropriate number of times,according to the process 480, to provide therapy to the subject 62. Thetherapy to the subject 62, therefore, may be made by the ID 30 accordingto the process 480 based upon a selected calibrated or determined sensorsignal level or value for various sensor inputs, as discussed above. Thestimulation may then be turned on or turned off based upon a comparisonof sensed values to the calibrated or determined recalled values, suchas in determination block 544.

With continuing reference to FIGS. 6A-6C, and additional reference toFIG. 8, a process for allowing the determination of a selected orappropriate stimulation pattern for the subject 62 (e.g. including anoptimal or selected optimal configuration), may be made. Theconfiguration of the stimulation may be made or tested based upon aplurality of different configurations.

As illustrated in FIGS. 6A-6C, exemplary configurations of stimulationbetween one or more of the contacts 192, 194 of the electrode ends 40,44, may be made. A selected list of all possible configurations and/orselected configurations may be determined. The selected or possibleconfigurations, thereafter, may be tested on the subject 62 to assist indetermining an optimal or selected optimal stimulation configuration.

Accordingly, with reference to FIG. 8, a testing and/or stimulationprocess 620 is illustrated. The process 620 may be a stimulation orelectrode configuration stimulation testing process. The process 620 maystart in start block 630. After the start block 630, such as afterimplantation of the ID 30 into the subject 62 and/or selection ofimplantation (e.g. prior to a procedure), a construction or recall listof possible candidate electrode configurations may be made in block 638.The list of possible electrode configurations for stimulation mayinclude those exemplary illustrated in FIG. 6A, FIG. 6B, and FIG. 6C.Further, it is understood, that additional stimulation configurationsmay be made or determined and may be included in the list in block 638.Accordingly, the exemplary configurations discussed above are notintended to be a limit of possible stimulation configurations to thesubject 62.

Following the construction or recall of the list of possibleconfigurations, a determination of a plurality of testing schemes may bemade and/or is scheduled for each set of configurations to be tested inblock 642. The schedule of testing may be made based upon the list, andmay be set for a number of hours, days, sleep cycles, or the like. Forexample, the configuration as illustrated in FIG. 6A may be determinedto be tested first, followed by the configuration illustrated in FIG.6B, followed by the configuration illustrated in FIG. 6C. It may bedetermined to test each configuration for a selected number of sleepcycles, a selected number of sleep hours, or any other appropriate time.Further the testing configurations may be scheduled for a period afterimplantation, such as beginning a testing period after a certain numberof sleep cycles, sleep hours, or the like. Nevertheless, a selectedschedule may be determined.

Following the determination of the testing schedule a storage of thetesting schedule may be made in block 650. The storing in block 650 maybe storing the test schedule, including the configurations, in anappropriate memory, such as the memory module 54 of the ID 30. It isunderstood that the testing schedule may also be stored in anyappropriate memory, such as the memory 102 of the CTM 70. As discussedabove the CTM 70 may transmit a signal to the ID 30 to be executedthereby (e.g. the CTM 70 transmits instructions to the ID 30 to beexecuted by the processor 50). Thus, the configurations and testingschedule may be stored in any appropriate memory to be executed by theID 30.

After storing the schedule in block 650, a determination of whetherstimulation should be initiated in block 654 may be made. Thedetermination of initiation of stimulation may be based on appropriateor selected input including a determined or sensed position of thesubject 62, an input of the CTM 70, a proximity to the CTM 70, or otherappropriate inputs. The initiation of stimulation may be similar to thatdiscussed above, such as in the process 480.

If initiation of stimulation is not determined to be appropriate inblock 654, a NO path 658 may be followed to return to the stored recallof the testing schedule in block 650. Thus, the initiation ofstimulation may be used to determine or create a loop to allow forrecall at appropriate stimulation schedules, such as a testing schedule,to be performed of an ID 30. The determination of whether stimulationshould occur may be looped to ensure that the stimulation schedule ismaintained or determined over an appropriate period of time.

If initiation of a stimulation is determined to be proper, a YES path662 may be followed to recall or access determined rules for therapy inblock 668. The recalled rules for therapy may be similar to thosediscussed above, including initiating a particular therapy based uponvarious inputs and/or sensor signals. Accordingly, sensor signals mayinclude a position of the ID 30 and/or various other sensor inputs suchas an EMG, oxygen saturation, or the like. Nevertheless, the therapy maybe provided from the ID 30 according to the rules recalled in block 668.Accordingly, the rules 668 may be included in instructions that arestored in the memory module 54 that may be executed by the processormodule 50 by the ID 30.

The stimulation, once initiated in block 654, and following the rules orinstructions as recalled in block 668, may be stimulated according toone of the selected schedules or configurations in block 674. Asdiscussed above, a plurality of configurations may be stored in block650. Accordingly, during a testing or configuration phase, such asduring the process 620, a selected one of the stimulation configurationsmay be made in block 674 for testing or stimulating the subject 62.Thus, for example, during a first testing period the configuration isillustrated in FIG. 6A may be sued to stimulate the subject according tothe rule recalled in block 668.

During stimulation according to a selected one of the plurality ofstored configurations, as selected in block 674, a record ofeffectiveness of the therapy may be made in block 680. The record may bebased upon various sensors incorporated or included with the ID 30, wornby the subject 62, (e.g. the external sensor 61′), or other appropriatesensors related to the ID 30. In various embodiments, for example,oxygenation saturation may be sensed, a breath rate may be sensed, orother appropriate information may be sensed and stored with the ID 30.As discussed above, the CTM 70 may also be provided for user access bythe subject 62. The subject 62 may enter or provide feedback regarding aselected sleep cycle which may be related to a selected one of the testsselected or used to stimulate the subject in block 674. Accordingly, thesubject may input information regarding perceived comfort, sleepeffectiveness, or other appropriate information. Further, variousadditional sensors may be provided that may provide input or sense thesubject 62 during a selected period.

The information recorded in block 680 may be stored in any appropriatememory, such as the memory module 54, the memory module 102, and/orother appropriate memory module. At a selected time, the information maybe recalled for further determination and/or analysis. Nevertheless, thevarious sensors may record and/or store information regarding the sensedparameters of the subject 62 and/or the subject 62 may input informationregarding the sleep.

The recorded information may then be output for a selected analysis inblock 684. The output may be transferred to the CTM 70, the CTM 74, orother appropriate systems. Nevertheless, the output may be stored forfurther analysis, such as after a selected number of sleep cycles. Thevarious memory modules may include capacity to store an appropriateamount of sensor data and/or user input data for further analysis.

After output of the results in block 684, and/or storage of the resultsin block 680, a determination of whether more electrode configurationsare to be tested may be made in block 690. If further configurations areto be tested, a YES path 694 may be followed to determine whetherinitiation of stimulation should occur in block 654. As discussed above,a plurality of electrode configurations may be made, such as theconfiguration of FIG. 6B and/or the configuration in FIG. 6C and/orother additional configurations. The decision block 690 may be used todetermine whether additional configurations of the electrodes have beenincluded in a list of possible electrode configurations for testing. Itis understood, as discussed above, that any appropriate number ofelectrode configurations may be stored for testing on the subject 62.

If a determination is made in block 690 that additional configurationsof electrodes is not to be tested, a NO path 700 may be followed. Infollowing the NO path 700, a determination of whether a selectedconfiguration is to be used and/or a selected configuration is anoptimal configuration may be made in block 710. A determination of aselected configuration may be selecting a configuration that achieves aselected or optimal result for the subject 62. As discussed abovevarious sensors may be used to sense the subject 62. For example, abreath rate and/or oxygenation saturation may be measured of the subject62. Accordingly, a stimulation configuration that achieves a selected ormost optimal sensor recording or rating of selected sensor outputs maybe used or determined to be an optimal configuration for the subject 62.For example, a blood oxygenation saturation level may be weighted as thefactor most relevant. Accordingly, the electrode configuration thatachieves the highest average, highest optimal, or other appropriatethreshold level of oxygenation saturation may be used or related to aparticular configuration of the electrodes and this configuration may bedetermined to be the optimal or selected for the subject in block 710.The selection in block 710 may be based upon an efficacy of the therapyfor the subject 62. The efficacy may be based on achieving selected orthreshold sensor values.

In various embodiments, the selected sensor readings may be based on thesingle subject or a population. For example, Oxygen saturation levelsmay be selected to be read at or near about or above about 95% andselected to be maintained or sensed above at least about 90% forselected sleep periods. A normal or selected therapy respiration ratefor an adult may be about 12 to 20 breaths per minute. A heart rate maybe selected to be achieved or therapy may be provided to maintain about40 to about 100 beats per minute (BPM) during sleep. Also, combinationsof sensor readings may be used such as coupling a drop in oxygen levelalong with an arousal (registered by accelerometer measuring movement)may also be an alert that insufficient stimulation is being deliveredmeant to avoid apnea/hypopnea. One or more sensor inputs may be used toconsider quality of sleep optimization with requisite feedback sensors(e.g. EEG, etc.).

The selected or optimal configuration in block 710 may be made or basedon a determination of an efficacy of the treatment including thestimulation therapy based on the output results from block 684. Thedetermination of the optimal electrode configuration made in block 710may be made based on the efficacy. The efficacy may be based on ordetermined as a comparison of the data values in block 680 to apredetermined value threshold and/or a subject threshold or response.For example, a threshold may be determined for oxygenation. The storedvalue in block 680 and output in block 684 may be compared to apredetermined oxygenation threshold. An efficacy (e.g. efficacy value)may be determined based on whether the predetermined threshold isachieved or exceeded and by what amount. Thus, a more or greaterefficacious therapy may include an electrode configuration that achievesa greater oxygenation than another configuration. It is understood,however, that efficacy may be based upon more than one value (e.g.sensor value) and/or weights of different parameters.

Thresholds may be those that are outside normal or selected ranges, asnoted above. Selected thresholds may also be subject specific andcalibrated and stored for each subject. For example, if blood oxygenlevels are below about 95. No standard or lack of movement during sleepas registered by the position sensor (e.g. an accelerometer). No or lackof normal chest excursion. For example, a position sensor in/on a chestof a subject could register excursion/movement and if the chest stopsmoving for 10 seconds (i.e. possible apnea event) then that could beavoided by stimulating or increasing or initiating stimulation.

Once a determined optimal configuration is made in block 710, the ID 30may be set to this configuration in block 720. Accordingly, for example,the ID 30 may be implanted with a set of test configurations. The set oftest configurations that are recalled in block 650 may then be tested inthe subject 62 over a selected period of time, according to the process620. After a determination of an optimal or selected configuration ismade in block 710, the ID 30 may be set with the selected configurationin block 720. Thus the subject 62 may experience therapy according tothe selected configuration of the electrodes set in the ID in block 720.

The electrode configuration may be set in block 720 at any selectedtime. For example, as noted above, the process 620 may be selected torun for a set period of time. It is understood, however, that thedetermination in block 710 may be substantially in real time. Forexample, the processor 50 may receive inputs and determine a selectedthreshold is not met (e.g. oxygenation). If a threshold is not met, theprocessor may recall a different electrode configuration from block 650for stimulation. Thus, the process 620 may allow for substantially realtime (e.g. once or more during a current or single sleep cycle)determination and stimulation with an electrode configuration.

The process 620 may further include a determination of whether a newtest phase is to occur in block 730. A new test phase may occur at anyappropriate period based upon a selected signal. For example, after athree month time period, a selected number of sleep cycles, or the like,a new test phase may be made in block 730. One or more of the CTM's 70,74 may be used to initiate a new test phase in the ID or determinationblock 730. Accordingly, the process 620 may be used to test a selectednumber of configurations at any appropriate time. Further, it isunderstood, that the CTM's 70, 74 may be used to transmit furtherconfigurations to the ID 30 for additional testing.

If no additional testing is to be performed, a NO path 734 may befollowed to end the process in block 738. The process 620, however, maybe re-initiated at any appropriate time, according to the processesdiscussed above.

Further, if a new test phase is determined in block 730, a YES path 742may be followed to determine whether initiation of stimulation should bemade in block 654. Accordingly, for example, the subject 62 may have avisit with a clinician at a selected time and the clinician maydetermine that an additional test phase should be performed. Theclinician may initiate a new test phase with the CTM 74 by transmittinga signal to the ID 30. The ID 30 may then determine the that a new testphase should occur in block 730 and the YES path 742 may be followed todetermine whether initiation of stimulation should occur in block 654.Accordingly, even if the subject 62 visits a clinician during anon-sleep period, the clinician may initiate a new test phase in block730 and the test phase may reinitiate by following the YES path 742.

As discussed above, processes and methods may be used to operate and/ordetermine a selected or optimal operation with ID 30, e.g. waveform forstimulation, for therapy to be provided to the subject 62. Accordingly,with reference to FIGS. 5A-5G, and additional reference to FIG. 9, aprocess or method 820 is illustrated. The process 820, as discussedfurther herein, may be used to determine or select an appropriatestimulation waveform pattern to be provided to the subject. For example,as illustrated in FIG. 8, the process 620 may be used to determine orselect a selected (e.g. optimal) configuration for stimulation of theelectrode provided on the electrode tips 40, 44. In addition, and/oralternatively thereto, a stimulation wave pattern may also be testedand/or selected for the subject 62. As illustrated in FIGS. 5A-5G,exemplary stimulation wave patterns may be provided by the ID 30.Accordingly, the process 820 may be used to determine (e.g. test) and/orselect a wave pattern that may be optimal for the subject 62 to providean appropriate or selected therapy thereto.

With reference to FIG. 9, therefore, the process 820 is illustrated. Theprocess 820 may begin at start block 830. The start block 830 may be anyappropriate start, as discussed above, including selecting the ID 30,implanting the ID 30, initiating (e.g. powering and selecting an initialstart period), or other appropriate configuration of the ID 30.Following the initiation of the start block 830, and/or at theappropriate time, a selected list or possible waveforms may bedetermined in block 834. The waveforms constructed or determined mayinclude those, as discussed above, including those illustrated in FIGS.5A-5G. The waveforms may include the stimulation time, overlap ofstimulation, amplitude of stimulation, period of stimulation, or otherappropriate waveforms. As discussed above, the waveforms may includemore than those illustrated in FIGS. 5A-5G and the particular waveformsare provided merely for illustration. Thus, the ID 30 may be used toprovide stimulation to the subject in an appropriate manner according tovarious waveforms or types of stimulation, as discussed above. The listof selected waveforms may include any appropriate or all possiblewaveforms provided by the device, or lists selected by the user 62,clinician, or other appropriate individual.

Once the list of possible waveform patterns is determined in block 834,a testing schedule for each of the waveforms may be made in block 838.The testing schedule, similar to the testing schedule in block 642discussed above, may include a length test including a number of sleepcycles, a number of days, or the like. The testing pattern may allow fordetermination or selection of a number of data points to be collectedfor each of the possible or selected sleep stimulation patterns asdetermined in block 834.

Once the schedule is determined by block 838 of the various patternsfrom 834, the testing scheme schedule may be stored in block 844. Thestorage of the testing scheme may include storage of the particularpatterns from block 834, the schedule from block 838, or otherappropriate considerations. Further the storage in block 844 may bestored into any appropriate memory module, such as the memory module 54of the ID 30, the memory module 102 of the CTM 70, or other appropriatememory module. Regardless the testing scheme may be recalled at anappropriate time, for testing and operation of the ID 30 according tothe appropriate manner.

Once the testing scheme has been stored and provided for recall during aselected testing phase, a recall of determined rules for initiationand/or continuation of stimulation may be made in block 850. Thedetermined rules for initiation and/or continuation of the therapy (e.g.therapy for OSA and/or UARS) may be stored in an appropriate memorymodule, such as the memory module 54 of the ID 30. As discussed abovethe rules may include when and how to initiate OSA therapy, intensity,or the like. As illustrated in the process 820, however, the variousstimulation patterns may be tested therein, and the rules recalled theblock 850 may include general rules regarding initiation of stimulationtherapy and/or appropriate configuration of the electrodes forstimulation, as discussed above.

After recall of the rules of block 850, a determination of whether toinitiate stimulation in block 854 may be made. The determination ofinitiation of therapy may be based upon various sensors provided withthe subject 62 (e.g. sensor 61, 61′), initiation by the CTM 70,proximity to the CTM 70, or other appropriate initiation feature. Thedetermination of whether initiation of the stimulation should begin inblock 854 may be based upon the rules recalled in block 850.

If an initiation is not performed in block 854, a NO path 856 may befollowed which may loop back to the initiation of stimulation atdetermination block 854. The loop may include a selected time delay,pause for receiving instructions from the CTM 70, or other appropriatefurther input.

If initiation stimulation is determined to occur, a YES path 860 may befollowed to stimulate the subject per at least one of the recalledtesting scheme schedules in block 864. As discussed above, a pluralityof wave patterns may be determined and stored in block 844. The selectedwave pattern or one of the selected wave patterns may be then used tostimulate the subject in block 864 once stimulation is initiated byfollowing the YES path 860.

During the stimulation in block 864, a sensing and/or recording of theeffectiveness and/or sensors relative to the subject 62 during thetherapy may be made. For example oxygenation levels, breathe rates, EMGvalue, apnea-hypoapnea index (AHI) index or values may all orselectively be measured and/or recorded and stored for later analysis.For example, various sensors in the subject, such as the sensors 61,61′, may be used to sense various data relative to the subject 62. Theinformation may be recorded and stored in selected memory modules, suchas the memory module 54 on the ID 30 and/or may be transmitted forstoring on additional memory modules such as the memory module 102 ofthe CTM 70.

Thus, the values from the sensors may be sensed and recorded in block868. The data may be outputted in block 872 for further analysis, suchas determining an effectiveness of the selected test stimulationpattern. The data may be outputted in one or more of the screens, suchas the screen 92 of the CTM 70, the screen 124 of the CTM 74, or otherappropriate output. The output may occur at any appropriate time, suchas after a selected one of the sleep cycles, one of the completion ofthe scheduled waveform patterns, or other appropriate time.

After one or more test periods, a determination of whether morecandidate waveforms are to be tested may be made in block 880. If adetermination is made that additional waveforms should be tested, a YESpath 884 may be followed to return to the initiation of stimulationdetermination block 854. Thus, the stimulation of the subject of 864 maybe according to a different or selected additional waveform pattern toallow for sensing and recording of the subject 62 in block 868.

Once a selected number of waveforms have been tested, or no additionalwaveforms are determined to be tested block 880, a NO path 890 may befollowed. When following the NO path 890 a determination of a selectcandidate waveform for stimulation may be made in block 894. Theselected stimulation waveform in block 894 may be an optimal waveformfor stimulation of the subject 62. An optimal waveform may be a waveformthat provides a selected therapy to the subject, such as based upon thesensed data in block 868. Furthermore, it is understood, that a selectedone of the sense values may be weighted greater than others andtherefore an optimal waveform may not be based upon a single valueand/or may include a selected optimal range for one sensed value, butnot for another. A determination of an optimal waveform may includeanalysis of the sensor data, as discussed above, regarding theconfiguration of the electrodes for stimulation. The selection in block894 may be based upon an efficacy of the therapy for the subject 62. Theefficacy may be based on achieving selected or threshold sensor values.Threshold levels may be subject selected or determined, but may includelow SPO2 values (e.g. less than about 90%), high breathing rates (e.g.above about 15 breathes per minute) or high heart rate (e.g. above about100 BPM). In various embodiments, Quality of Sleep may be a therapyfeedback loop for optimization. Thus, Quality of Sleep may be anindication of therapy effectiveness and/or efficacy.

The selected or optimal waveform in block 894 may be made or based on adetermination of an efficacy of the treatment including the stimulationtherapy based on the output results from block 868. The determination ofthe optimal waveform made in block 894 may be made based on theefficacy. The efficacy may be based on or determined as a comparison ofthe data values in block 868 to a predetermined value threshold and/or asubject threshold or response. For example, a threshold may bedetermined for oxygenation. The stored value in block 868 and output inblock 872 may be compared to a predetermined oxygenation threshold. Anefficacy (e.g. efficacy value) may be determined based on whether thepredetermined threshold is achieved or exceeded and by what amount.Thus, a more or greater efficacious therapy may include a waveform thatachieves a greater oxygenation than another waveform. It is understood,however, that efficacy may be based upon more than one value (e.g.sensor value) and/or weights of different parameters, such as thosenoted above.

After determining the selected waveform of block 894, the waveform maybe set in block 900. By setting the waveform in block 900, the selectedwaveform may be programmed or selected in the ID 30 to providestimulation to the subject 62 for a selected period of time. Forexample, the testing phase 820 may be used to test or select a waveformfor stimulation of the subject 62 with the ID 30. After a selectedtesting phase, or selected time, the selected waveform may be selectedin the ID 30 and set as the stimulation waveform. Thus, for example,after a period of testing (e.g. one month) the ID 30 may be set to aselected waveform for providing the selected (e.g. optimal) therapy tothe subject 62.

The waveform may be set in block 910 at any selected time. For example,as noted above, the process 820 may be selected to run for a set periodof time. It is understood, however, that the determination in block 894may be substantially real time. For example, the processor 50 mayreceive inputs and determine a selected threshold is not met (e.g.oxygenation). If a threshold is not met, the processor may recall adifferent waveform from block 838 for stimulation. Thus, the process 820may allow for substantially real time (e.g. once or more during acurrent or single sleep cycle) determination and stimulation with awaveform.

It is understood, however, that after a selected period of time, a newtest phase may be selected or determined in block 910. Selecting newtest phase in block 910 may be any appropriate selection of a new testphase, such as after a passage of a selected time, selection by aclinician such as transmitting a signal from the CTM 74, or otherappropriate selection. Accordingly, the new test phase may be made inblock 910.

If a new test phase is determined in block 910, a YES path 914 may befollowed to construct or recall a list of possible candidate waveformsin block 834. The process 820, therefore, may be repeated at a selectedtime. It is understood that the list in block 834 may be the same listas discussed above, and simply be retested as the subject 62 may changeover time (e.g. gain muscle rigidity, strength, or the like).

Further, if a new test phase is not determined to occur, a NO path 920may be followed and the process 820 may end in block 924. Ending theprocess in 924 may include stimulating the subject 62 according to theselected waveform in block 900 for stimulating the subject in anappropriate time or manner. Thus, the process 820 may be used to testand/or select an appropriate or optimal waveform for the subject 62.

Accordingly, as discussed above, the ID 30 may be used to providestimulation to the subject 62 in an appropriate manner. The ID 30 may beused to configure the electrodes or to provide stimulation to a selectedconfiguration of the electrodes so the electrode tips 40, 44 in variouspatterns or configurations. Further, various waveforms may be used tostimulate the subject 62. These selected configurations and/or waveformsmay be tested or selected over a selected period of time, such as afterimplantation of the ID 30. It is understood that a combination of bothconfigurations of the electrodes, waveforms, or sensed information fromthe subject 62 may all be tested simultaneously, sequentially, or thelike to determine an optimal configuration, waveform, and other factorsor parameters relative to subject 62 to provide therapy to the subject62. Thus, the ID 30 may be used to provide stimulation to the subject 62in a manner to substantially reduce and/or eliminate fatigue of thelingual muscle 170 and/or provide a selected or optimal therapy to thesubject 62 to provide therapy for selected conditions, such as OSA,UARS, or other appropriate conditions.

Turning to FIG. 10, a process or system 1000 is illustrated. The system1000 may be used to assist in generation of parameters for a therapy tothe subject 62, or any appropriate subject. In various embodiments, theprocess 1000 may be a machine learning process that may incorporate oruse any appropriate machine learning algorithm (e.g. regressionanalysis, supervised or unsupervised algorithms, neural networks, orcombinations thereof). The machine learning process 1000 may allow foracquisition or usage of data from a plurality of subjects and/or onesubject, for generation of a particular therapy parameter.

For example, population parameters or data 1010 may be collected.Individual parameters or data may also be collected in block 1020. Theparameters may be substantially identical between the population inblock 1010 and the individual in block 1020. For example, parameters mayinclude body mass index (i.e. including body mass), blood pressure,oxygen saturation in blood and tissue, EMG (e.g. chin EMG, thoracic orarterial EMG, or the like), breathing rate, pulse rate, or otherappropriate parameters. Parameter values may be collected from apopulation in block 1010 or from an individual in block 1020 and mayinclude those collected during selected studies such as a sleep study.As discussed above, a sleep study of an individual or population ofindividuals may include acquisition of data in a polysomnography. In thesleep study, various parameters may be collected regarding theindividual during an alert state, a sleep state, a vertical position,horizontal position, or other orientations of the subject. Variousparameters may include those as discussed above, including oxygenationlevels, brain waves, muscle activation in various areas of the body of asubject, and other appropriate parameters. The various parameters may beused to identify or determine onset and/or currents of an apneicepisode. For example, a breathing rate, oxygenation level, or the likemay be used to determine or understand a severity, length, or the likeof an apneic episode. The subject, such as the subject 62, may then bestimulated or have therapy applied thereto in an appropriate manner toassist in correcting or stopping the apneic episode.

The population parameters or data 1010 may include data regarding apopulation, such as a plurality of patients. The data may include dataregarding the patient (e.g. body mass and health conditions) and variousparameters for stimulation of a lingual muscle for each of thepopulation. Thus, the population data 1010 may include a stimulationparameters (e.g. waveform and/or lead configuration) for treatment ofOSA. The population data may further include a determined efficacy (e.g.expert or clinician determined efficacy) for the applied therapy. Thepopulation data may include various inputs (e.g. sensor inputs andsubject inputs) regarding the subject during stimulation. The inputs mayinclude those as discussed above include apneic event duration,frequency, oxygen saturation, etc. Thus, the efficacy may be determinedbased on the various inputs during the stimulation.

Regardless, the population parameters from block 1010 and the individualparameters from block 1020 may be acquired and input into a machinelearning system in block 1030. The machine learning system 1030 mayinclude a selected algorithm, such as those discussed above and variousweights for the parameters. The machine learning system may acquire andanalyze the parameters from the population in block 1010 and individualsin block 1020. The weights and algorithm associated with the machinelearning system in block 1030 may be used to determine an appropriatetherapy parameter.

The therapy parameter may then be determined and output in block 1040.The therapy parameter may include various features, such as thosediscussed above, including stimulation waveforms, lead configurations,various inputs from sensors associated with a subject 62, and the like.As discussed above, various inputs may include accelerometers toindicate position of the subject 62, oxygenation sensors to determine anoxygen saturation in various locations of the subject, and otherappropriate sensors including those discussed above.

The therapy parameters output in block 1040 may include parametersregarding an initiation of therapy, a waveform of therapy, aconfiguration of the electrodes for therapy, or the like. Further,therapy parameters may include a plurality of sets of therapy parametersthat may be studied or tested relative to the subject 62, as discussedabove. In various embodiments, however, the therapy parameters output inblock 1040 may include a single set of parameters including a waveform,electrode configuration, and selected sensor inputs (e.g. for initiationof stimulation include subject position, breathe rate, etc.).

Thus, the ID 30 may be programmed after implantation based upon themachine learning system 1030 that may include population parameters fromblock 1010 and individual parameters from block 1020. In variousembodiments, the individual parameters in block 1020 may include a sleepstudy of the individual subject, which may include information regardingapneic episodes during the sleep study. Accordingly, the therapyparameters in block 1040 may include initiating therapy based upon adetermined position of the subject (i.e. with a sensor), signal receivedby the ID 30 regarding initiation of therapy, or the like. The therapyparameters from block 1040 may further include the specific waveformthat may be selected (e.g. by a clinician), the population parameters1010, or feedback, as discussed further herein.

The therapy parameters output in block 1040 may be used or applied to asubject, such as in optional application of therapy in block 1050. Theapplication of therapy in block 1050 may include the application oftherapy to the subject 62 based upon the therapy parameters output inblock 1040. The therapy parameters may be stored in the ID 30 such asduring an ID 30 programming, programming with the CTM's 70, 74, or otherappropriate programming. The subject 62 may then have the therapyapplied for a selected period of time in block 1050, such as over acertain number of sleep hours, sleep cycles, set period of time, or thelike. It is understood that the application of therapy in block 1050,however, is not required for the process 1000, but is included ordisclosed for clarity thereof.

A therapy analysis may happen in block 1060. The therapy analysis mayinclude the data collected during the application of therapy in block1050 based on the therapy output in block 1040. The therapy analysis inblock 1060, however, may be an analysis of any appropriate therapy data.Therapy analysis may include data regarding a number of apneic episodes,length of apneic episodes, severity of apneic episodes (e.g. oxygensaturation, brain wave, or other appropriate considerations). Theselection or analysis in block 1060 may be based upon an efficacy of thetherapy for the subject 62 or population of subjects. The efficacy maybe based on achieving selected or threshold sensor values and/or ofsubject or population feedback. Also, an increase or greater efficacymay be achieved when one or more thresholds is reached or valuesimproved upon (e.g. greater oxygenation) relative to a different therapyparameter.

In various embodiments, efficacy may be determined or evaluated based ona reduction of a severity of apneic events. Various factors may includeoxygen saturation levels, heart rate, and length of time of undesirableindications may relate to severity. For example, low or very low oxygensaturation levels (e.g. below about 85%) may be severe, where the lowerthe levels the more severe the apneic event. A very high heart rate(Indicating high sympathetic tone) (e.g. above about 100 BPM) may besevere, where the higher the levels the more severe the apneic event.Also, a long period (e.g. minutes) of undesirable factors (e.g.oxygenation levels, heart, rate, etc.) may be severe, where the longerthe time period the more severe the apneic event. Also, the greater thenumber of apneic events may relate to a more severe or a lessefficacious treatment. Other indications may include reduced or noairflow. In general, apnea event could be a trigger for other cardiacarrhythmias (slow HR<30 bpm, syncope pause more than 3 seconds, AF,etc.).

The therapy analysis may be performed by or with the ID 30, the CTM's70, 74, or any appropriate system. The therapy analysis may include thedetermination of a success or optimization of a selected therapy outputin block 1040. Accordingly, as discussed above, the therapy analysis inblock 1060 may include a determination of the number of apneic episodesduring a period of sleep (e.g. a rate of apneic episodes per sleepminutes or hours), and/or other factors of the subject 62.

The therapy analysis may be used to provide a feedback 1070 to themachine learning 1030. The feedback may include a simple feedback, suchas a number of apneic episodes the selected therapy from block 1040, orother appropriate feedback. For example, the feedback may include thesubject feedback regarding sleep success, sleep quality, or the like.The feedback, therefore, may be provided to the machine learning system1030 to analyze or include the therapy analysis from block 1060 and thevarious population in individual parameters 1010, 1020.

As discussed above, machine learning may include selected algorithms andvarious features of the algorithms, such as weight, to assist indetermining an appropriate therapy parameter. Thus the feedback 1070 mayallow for a change or optimization of therapy parameters that may thenbe output in block 1040. The therapy analysis may then occur in block1060.

The process 1000 may then loop, therefore, to analyze a plurality oftherapy analysis from block 1060, and/or parameters to provide ordetermine a therapy for the subject 62.

The process 1000, therefore, can be understood to be a loop or iterativeprocess to achieve a therapy for the subject 62. The loop process 1000,therefore, may include an end-loop determination, such as determiningwhether further study is to occur in block 1080. If further study is tooccur in block 1080, a YES path 1084 may be followed into the feedbackloop 1070. Thus, the machine learning process 1000 may be used todetermine an optimal therapy for the subject 62, or selected therapy forthe subject 62, based upon the various therapy analyses in block 1060.The feedback 1070 may be long term, such as over a plurality of sleepcycles, and/or may be short term or real time, such as during a currentsleep cycle. In real time, for example, the feedback may be that anapneic event is extending longer than a selected time threshold or thatoxygenation levels are below a threshold. Thus, the therapy parametersmay be altered in real time once the determination is made that one ormore thresholds have been reached

If further study is not required or selected, a NO path 1088 may befollowed to end in block 1090. The ending in block 1090 may be aprogramming of the ID 30 for a selected time, such as a selected periodof time, selected sleep cycle, or the like. The therapy for the subject62 may be based upon the analysis, therefore, of the subject 62individually and/or a population of subjects. The population of subjectsfrom which the population parameters are required in block 1010 mayinclude those with or that have been diagnosed with sleep apnea, thosethat have not been diagnosed with sleep apnea, individuals of variousbackgrounds, and the like. Thus, the population parameters 1010 may beused to provide or determine a selected or universal set of parametersregarding a subject, including those with sleep apnea. The process 1000,therefore, may be used to provide a therapy to the subject withoutlimitation to only an individual parameter, such as an individual sleepstudy of the individual 62 to have therapy applied thereto.

Thus, as discussed above, a therapy may be applied to the individual orsubject 62 the ID 30 based upon various parameters. The parameters mayinclude waveform of stimulation, configuration of electrode contacts forstimulation, sensor inputs to determine when and/or a magnitude ofstimulation, and/or other parameters for therapy and input. Further,various portions of the stimulation system 20, such as the processor 50of the ID 30, may execute instructions per selected processors fordetermination of whether stimulation should be initiated, as discussedabove in the process 480. Also, the system 20 may be used to selectedand/or implement one or more stimulation parameters (e.g. waveform,electrode configuration, etc.) for providing a therapy to the subjectwith a selected efficacy. The system 20 may operate to make thedetermination and/or implement the therapy by one or more of theprocesses 620, 820, or 1000 as discussed above. Also, a combination ofone or more may be used, such as selecting both a waveform and anelectrode configuration for therapy.

It should be understood that various aspects disclosed herein may becombined in different combinations than the combinations specificallypresented in the description and accompanying drawings. It should alsobe understood that, depending on the example, certain acts or events ofany of the processes or methods described herein may be performed in adifferent sequence, may be added, merged, or left out altogether (e.g.,all described acts or events may not be necessary to carry out thetechniques). In addition, while certain aspects of this disclosure aredescribed as being performed by a single module or unit for purposes ofclarity, it should be understood that the techniques of this disclosuremay be performed by a combination of units or modules associated with,for example, a medical device.

In one or more examples, the described techniques may be implemented inhardware, software, firmware, or any combination thereof. If implementedin software, the functions may be stored as one or more instructions orcode on a computer-readable medium (e.g. memory module) and executed bya hardware-based processing unit. Computer-readable media may includenon-transitory computer-readable media, which corresponds to a tangiblemedium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory,or any other medium that can be used to store desired program code inthe form of instructions or data structures and that can be accessed bya computer).

Instructions may be executed by one or more processors (e.g. processormodule), such as one or more digital signal processors (DSPs), generalpurpose microprocessors, graphic processing units (GPUs), applicationspecific integrated circuits (ASICs), field programmable logic arrays(FPGAs), or other equivalent integrated or discrete logic circuitry.Accordingly, the term “processor” as used herein may refer to any of theforegoing structure or any other physical structure suitable forimplementation of the described techniques. Also, the techniques couldbe fully implemented in one or more circuits or logic elements.

Example embodiments are provided so that this disclosure will bethorough, and will fully convey the scope to those who are skilled inthe art. Numerous specific details are set forth such as examples ofspecific components, devices, and methods, to provide a thoroughunderstanding of embodiments of the present disclosure. It will beapparent to those skilled in the art that specific details need not beemployed, that example embodiments may be embodied in many differentforms and that neither should be construed to limit the scope of thedisclosure. In some example embodiments, well-known processes,well-known device structures, and well-known technologies are notdescribed in detail.

The foregoing description of the embodiments has been provided forpurposes of illustration and description. It is not intended to beexhaustive or to limit the disclosure. Individual elements or featuresof a particular embodiment are generally not limited to that particularembodiment, but, where applicable, are interchangeable and can be usedin a selected embodiment, even if not specifically shown or described.The same may also be varied in many ways. Such variations are not to beregarded as a departure from the disclosure, and all such modificationsare intended to be included within the scope of the disclosure.

What is claimed is:
 1. A method of stimulating a subject, comprising:placing a first lead in a lateral side of a tongue of the subject;placing a second lead bilaterally of the first lead in the tongue of thesubject; generating a first stimulation according to a first stimulationparameter for transmission through the first lead; and generating asecond stimulation according to a second stimulation parameter fortransmission through the second lead; wherein the first lead is spacedbilaterally from the second lead; wherein the first stimulationparameter differs from the second stimulation parameter.
 2. The methodof claim 1, wherein the first stimulation parameter is greater inmagnitude than the second stimulation parameter.
 3. The method of claim1, wherein the first stimulation is at a time different than the secondstimulation.
 4. The method of claim 1, wherein the first lead includes afirst electrode and a second electrode and the second lead includes athird electrode and a fourth electrode; wherein the first stimulation isbetween the first electrode and the second electrode; wherein the secondstimulation is between the third electrode and the fourth electrode. 5.The method of claim 1, wherein generating the first stimulationaccording to the first stimulation parameter includes providing a firststimulation wave form; wherein generating the second stimulationaccording to the second stimulation parameter includes providing asecond stimulation wave form different from the first stimulationwaveform.
 6. The method of claim 1, wherein generating the firststimulation according to the first stimulation parameter includesproviding a first stimulation amplitude; wherein generating the secondstimulation according to the second stimulation parameter includesproviding a second stimulation amplitude different from the firstamplitude.
 7. The method of claim 1, wherein generating the secondstimulation according to the second stimulation parameter includesproviding the second stimulation after stopping providing the firststimulation with the first lead.
 8. A method of stimulating a subject,comprising: providing a first lead end and a second lead end connectedto an implantable stimulation device; providing a first stimulationsignal from the implantable stimulation device to the first lead end tostimulate a first lateral portion of a tongue; and providing a secondstimulation signal from the implantable stimulation device to the secondlead end to stimulate a second lateral portion of the tongue; whereinthe second lateral portion is bilateral to the first lateral portion;wherein the first stimulation signal differs from the second stimulationsignal.
 9. The method of claim 8, wherein the first stimulation signaland the second stimulation signal both stimulate one or more portions ofa tongue.
 10. The method of claim 8, wherein providing the firststimulation signal includes providing a first stimulation wave form;wherein providing the second stimulation signal includes providing asecond stimulation wave form different from the first stimulationwaveform.
 11. The method of claim 8, wherein providing the firststimulation signal includes providing a first stimulation amplitude;wherein providing the second stimulation signal includes providing asecond stimulation amplitude different from the first amplitude.
 12. Themethod of claim 8, wherein providing the second stimulation signalincludes providing the second stimulation signal after stoppingproviding the first stimulation signal.
 13. A system for stimulating asubject, comprising: a first lead end; a second lead end; and animplantable stimulation device connected to both the first lead end andthe second lead end; wherein the implantable stimulation device isconfigured to deliver: a first stimulation signal to the first lead endto stimulate a first lateral portion of a tongue; and a secondstimulation signal from the implantable stimulation device to the secondlead end to stimulate a second lateral portion of the tongue; whereinthe second lateral portion is bilateral to the first lateral portion;wherein the first stimulation signal differs from the second stimulationsignal.
 14. The system of claim 13, wherein the first stimulation signalincludes a first stimulation wave form; wherein the second stimulationsignal includes a second stimulation wave form different from the firststimulation waveform.
 15. The system of claim 13, wherein the firststimulation signal includes a first stimulation amplitude; wherein thesecond stimulation signal includes a second stimulation amplitudedifferent from the first amplitude.
 16. The system of claim 13, whereinthe second stimulation signal includes the second stimulation signalafter stopping the first stimulation signal.